FDA Issues Q&A Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations

On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry DRAFT GUIDANCE.

The goals of this guidance are as follows:

• Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations

• Clarify and further expand on the risk-based approach described in the 2003 part 11 guidance to validation, audit trails, and archiving of records

• Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations

Click here to view the document.